510(k) K261335
- Device
- VitalFlow Set with Balance™ Biosurface
- Applicant
- Medtronic, Inc.
- 510(k) number
- K261335
- Product code
- QJZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-31
- Date received
- 2026-04-23
- Regulation
- 870.4100
- Classification name
- Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Vinoda Palanisamy
- Address
- 7611 Northland Dr. Minneapolis MN US 55428 55428
FDA Registration Numbers#
- 3016096143
- 9617601
- 9611665
- 3035708507
- 3012172416
- 3011468686
- 3030191221
- 3002845651
Source Documents#
Other 510(k) Records For Product Code QJZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024-09-12 |
| K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
| K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 |